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KETOCONAZOLE SHAMPOO LABELING SHOULD CONTRAINDICATE USE IN CHILDREN UNDER 12

This article was originally published in The Tan Sheet

Executive Summary

KETOCONAZOLE SHAMPOO LABELING SHOULD CONTRAINDICATE USE IN CHILDREN UNDER 12 years of age, FDA's Nonprescription Drugs and Dermatologic Drugs Advisory Committees recommended at a Feb. 16 joint meeting. Following a discussion of safety issues with ketoconazole 1% dandruff shampoo and an appropriate age restriction, the committees voted unanimously to recommend labeling that prohibits "use [of ketoconazole] in children under the age of 12" with the additional disclaimer that safety and efficacy trials have not been conducted in children.
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